None listed
Conditions
Brief summary
The Alfred Hospital is an adult major trauma centre, and receives in excess of 65,000 patient presentations per year. This study is an open-label randomised controlled trial of one dose of Methoxyflurane (3mL) administered after streaming to eligible patients compared to standard care. The primary outcome will be defined as the proportion of participants achieving significant pain reduction. We consider significant pain reduction as at least a 50% drop in the initial pain score at 30 min from presentation to the ED. Secondary outcomes will be the mean pain score at 30 min, the proportion of participants achieving a drop in pain scores of at least 3 standard points on the numerical 11-point pain scale, and the use of any opioid analgesia. Participants will be asked to indicate the intensity of pain at 30, 60, and 90 min after administration of analgesia, with a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available. Participants’ reported pain scores will be recorded contemporaneously and the participants will not be reminded of the previous score.
Interventions
Patient is given a single dose of Methoxyflurane (3mL) via Inhaler device over 90 minutes, and the patient is assessed at set intervals during this time (at 15min, 30min, 60min and 90min since the commencement of medication) via a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available.
Intervention adherence will be assessed by the patient self-reporting - if there is a issue with fidelity, the research assistant/data
Patient is given a single dose of Methoxyflurane (3mL) via Inhaler device over 90 minutes, and the patient is assessed at set intervals during this time (at 15min, 30min, 60min and 90min since the commencement of medication) via a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available. Intervention adherence will be assessed by the patient self-reporting - if there is a issue with fidelity, the research assistant/data collector will report as such on the case report form (CRF) and encourage the patient verbally to improve adherence to protocol.
Sponsors
Medical Developments International
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Adult patients (aged greater than or equal to 18 years, and less than or equal to 75 years) - Presentation to ED from home or scene of incident - Initial pain score of 8/10 or greater
Exclusion criteria
- Interhospital transfers - Haemodynamic instability (cardiovascular instability, respiratory depression, head injury or impaired conscious state) defined as vital sign measurements that would be within met call criteria (e.g. HR<40 or >140, SBP<90 or >180, RR< 6 or >36, GCS<14) - Pain possibly due to acute coronary syndrome - Patients presenting with headache - Pregnant patients or patients currently breastfeeding - Known renal/hepatic failure - Hypersensitivity to fluorinated anaesthetics - Malignant hyperthermia
Outcome results
None listed